14 October 2008 VIEW on ESolutions ECLINICAL Early electronic data capture focused on finding efficiencies in data management activities, such as data entry and cleaning. When eClinical hit the mainstream, it delivered a clear view of complete trial data on a realtime basis, enabling clinical trial project man agers (PMs) to generate summaries on the latest data. With this improvement over traditional EDC, the role of the project manager (PM) was allowed to evolve beyond administrative tasks to more analytical and strategic responsibilities.The role morphed from “are things getting done?” to “are things getting done efficiently and on time?” In general, eClinical allows for proactive and adaptive clinical trial management enabling more informed decisions to be made sooner. The next stage of this continuum integrates eClinical with business processes, seeking efficiencies throughout the entire development plan, including project tracking and accounting. Proactive Clinical Business Process Integration As the pendulum for eClinical swings beyond the tipping point, the evolution into business processes becomes inevitable. If accrued trial data can be viewed on a realtime basis, why can’t we do the same with the business process data surrounding the trial? With true clinical business process integration, PMs can view comprehensive trial metrics along with cost accounting reports, reducing the probability for surprises at the end of the trial and ultimately increasing the likelihood for success of the entire clinical development program. For example: Automating Product Tracking. The central repository of product at the manufacturer are linked with the randomization module, and then linked with product usage. Using product accountability information, reports are delivered to the manufacturing group and used to forecast the timing of new batches, issues with defective product, and usage patterns. This same concept can be applied to other trial parameters, such as imaging trends, laboratory samples, and kits. Project tracking and cost accounting. Using assumptions agreed upon in the contract, planned tasks are followed and linked with related costs. For example, if 100 monitoring trips are planned over 4 years and 25 SAS tables are to be delivered 5 business days after database lock, each of these pieces would be represented in a milestone tracking chart to be adjusted based on forecasted enrollment patterns or delays in trial execution. This information could be leveraged to forecast staff augmentation, both internally and externally, and linked with Human Resources applications to handle the complexities of staff expansion or reduction. Third party costs: Third party costs are tracked and authenticated against trial data streamlining the vendor management process. eClinical systems routinely monitor site payments based on data accrual and cleaning. Once linked with business processes, patient recruitment costs, such as advertising and education programs, can be looked at not only with budget agreements but also with web based enrollment tracking reports and with CTMSs to forecast trends, confirm assumptions, and adapt efforts as needed. A Living Dashboard As clinical trial operations and business process data become linked, reports can be delivered in a personalized “living” dashboard. Automated emails and status reports can be prepared to remind appropriate parties of milestones that are due, show the percentage of tasks completed, even show used and unused budget. With trial activity and project accounting more visible to the Sponsor via the living dashboard, an increased accountability and higher expectations are placed upon both the Sponsor and outsourcing partner. Team members need to have a strategic mindset throughout the course of a program and communicate ideas to one another to facilitate efficiencies. Pulling it All Together Companies are moving to flexible business models in efforts to find the lowest cost of ownership that provides the most efficient use of resources. Being able to make both critical and routine decisions faster based on data that is as close to realtime as possible enables pharmaceutical companies to stay one step ahead of their competition and, more importantly, one step ahead of the next potential roadblock. inVentiv Clinical Solutions INVENTIV CLINICAL SOLUTIONS, a division of inVentiv Health, provides flexible, scalable clinical development solutions, including trial management, monitoring, data management, statistics, medical writing, regulatory, and clinical staffing. For more information, visit inventivclinical.com. Where eClinical Meets Business Process The project manager role has morphed from “Are things getting done?” to “Are things getting done efficiently and on time?” Stacey Arrambide VP of Data Management Results… accelerate Contact us today at: P: 800.797.8287 [email protected] www.inventivclinical.com Find out how inVentiv Clinical can provide the control and flexibility you need to accelerate your clinical trial results! …with unmatched access to the highest quality clinical resources! Clinical Development Solutions Including clinical trial management, monitoring, data management, biostatistics, medical writing and regulatory affairs Strategic Resource Groups Custom built teams for access to longer term relationships with research critical personnel while avoiding co employment issues Contract Staffing Clinical and scientific contract staffing solutions through our industry leading staffing divisions, MedFocus and Smith Hanley Consulting Group

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